Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2025-01-21
Label type
Human OTC Drug Label
Version
4
Source
full-release
Hydrated at
2026-06-01 00:53:26

Label at a glance#

ProductNaproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache
Active ingredientNAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

temporarily relieves these cold, sinus, and flu symptoms:   sinus pressure minor body aches and pains headache nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) fever

Dosage and administration

do not take more than directed the smallest effective dose should be used swallow whole; do not crush or chew drink a full glass of water with each dose adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours children under 12 years: do not use

Storage and handling

each caplet contains: sodium 22 mg store at 20° to 25°C (68° to 77°F) store in a dry place Meets USP dissolution test 3.

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*
Pseudoephedrine Hydrochloride USP 120 mg, extended-release

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these cold, sinus, and flu symptoms:
 

  • sinus pressure
  • minor body aches and pains
  • headache
  • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
  • fever

Warnings

WARNINGS SECTION

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • in children under 12 years of age

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • fever gets worse or lasts more than 3 days
    • you have difficulty swallowing or the caplet feels stuck in your throat
    • you get nervous, dizzy, or sleepless
    • nasal congestion lasts more than 7 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • swallow whole; do not crush or chew
  • drink a full glass of water with each dose
  • adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: sodium 22 mg
  • store at 20° to 25°C (68° to 77°F)
  • store in a dry place
  • Meets USP dissolution test 3.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg / 120 mg 10 Caplets (Capsule-Shaped Tablets) Blister Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-832-83

*Compare to active
ingredients in
Aleve-D® Sinus & Headache

Naproxen Sodium and 
Pseudoephedrine Hydrochloride
Extended-Release Tablets, USP 
220 mg/120 mg

Non-Drowsy

THIS CARTON IS NOT CHILD RESISTANT

Pain Reliever/Fever Reducer (NSAID)
Nasal Decongestant

SINUS & HEADACHE

12 Hour Multi-Symptom Relief of

  • Sinus Pressure
  • Headache
  • Sinus Congestion
  • Nasal Congestion

10 Caplets
(1 x 10's blister)

AUROHEALTH                        1 Caplet - 12 Hours



Naproxen Figure
Naproxen Figure

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1367426naproxen sodium 220 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN4
136742612 HR naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD4
1367426naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-832-67Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE104
58602-832-67Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache2 in 1 CARTONTABLET, EXTENDED RELEASE24
58602-832-83Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache1 in 1 CARTONTABLET, EXTENDED RELEASE14
58602-832-83Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-832NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE SINUS AND HEADACHE (NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AUROHEALTH LLC]4Current NDC, Legacy NDC, 4 package rows20250124_10a8a74b-11d1-490e-87e7-d705fe0e7602.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-83258602-832-83, 58602-832-67

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDENAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-0184e616aacf4f…
2026-08-18 06:07:402026-07A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-015c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211360-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-06-01a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and HeadacheNAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC10a8a74b-11d1-490e-87e7-d705fe0e76022025-01-21WarningsExact identifier
ndc (package): 58602-832-67
ndc (package): 58602-832-83
ndc (product): 58602-832
ndc11 (package): 58602083267
ndc11 (package): 58602083283
spl id: 0287563f-3472-401d-b95f-9694258def17
spl set id: 10a8a74b-11d1-490e-87e7-d705fe0e7602

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.